Bioequivalence and Bioavailability Forum • Two-stage design and 'forced bioequivalence'

Two-stage design and 'forced bioequivalence' [Two-Stage / GS Designs]

posted by Yura – Belarus, 2018-06-07 12:24 (2004 d 05:08 ago) – Posting: # 18859
Views: 4,572

Hi Mikalai,
'forced bioequivalence' - it's not from "that opera".
If you took for 2х2х2 n = 120 for CL AUCt (90-111.11 - with narrow therapeutic index), CV = 16.5% and recommended GMR = 97.5%, while in calculation (in R) for 2х2х4 you get n = 30.
The sample size is twice as high as possible, which is not ethical - to expose an unknown effect of the test drug to more people than necessary.
If I understand correctly, that's it 'forced bioequivalence'
regards

Complete thread:

Two-stage design and 'forced bioequivalence' Mikalai 2018-06-06 08:28 [Two-Stage / GS Designs]
- Two-stage design and 'forced bioequivalence' ElMaestro 2018-06-06 10:53
  - Two-stage design and 'forced bioequivalence'Yura 2018-06-07 10:24
    - But what is the real problem? ElMaestro 2018-06-07 13:53
      - But what is the real problem? Yura 2018-06-07 14:59
        
        But what is the real problem? Mikalai 2018-06-07 15:47
        
        But what is the real problem? Helmut 2018-06-07 17:33
        
        But what is the real problem? Mikalai 2018-06-08 12:24
        
        U as a futility criterion Helmut 2018-06-08 14:00